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Generated: January 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209862

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NDA 209862 describes EVZIO, which is a drug marketed by Kaleo Inc and is included in two NDAs. It is available from one supplier. There are twenty-five patents protecting this drug. Additional details are available on the EVZIO profile page.

The generic ingredient in EVZIO is naloxone hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 209862
Applicant:Kaleo Inc
Ingredient:naloxone hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 209862
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 209862
Suppliers and Packaging for NDA: 209862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862 NDA kaleo, Inc. 60842-051 60842-051-01 2 DOSE PACK in 1 CARTON (60842-051-01) > .4 mL in 1 DOSE PACK

Profile for product number 001

Approval Date:Oct 19, 2016TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 1, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 15, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Oct 30, 2028Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Queensland Health
Cantor Fitzgerald

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